In-Depth Computer System Validation (CSV) for FDA Compliance 2019 is a webinar that covers topics such as:
- System Development Life Cycle (SDLC) Methodology
- Computer System Validation (CSV)
- Validation Planning
- Good "variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice, Good Clinical Practice (GCP)
- Risk Assessment
- GAMP 5 System Classification
- Configuration and Custom Coded Solutions
- Functional Requirements Specification
- Operational Qualification (OQ) Testing
- Installation Qualification (IQ) Testing
- Validation Summary Report
- Performance Qualification (PQ) Testing (User Acceptance Testing/UAT
- Policies and Procedures
- Operational Maintenance for Validated Systems
- Organizational Change Management (OCM)
- Training
- Disaster Recovery and Business Continuity Planning
- Periodic System Review
- FDA Recent Inspection Trends and Key Areas of Focus
- System Retirement
In-Depth Computer System Validation (CSV) for FDA Compliance 2019 is intended for:
- IT Developers
- Information Technology (IT) Analysts
- QC/QA Managers and Analysts
- IT Support Staff
- Compliance Managers and Auditors
- Clinical Data Managers and Scientists
- Computer System Validation Specialists
- Lab Managers and Analysts
- Business Stakeholders using Computer Systems Regulated by FDA
- GMP Training Specialists
- Consultants in the Life Sciences and Tobacco Industries
- Regulatory Affairs Personnel
- College Students Attending Schools and Studying Computer System Validation, Regulatory Affairs/matters (related to FDA)
- Interns Working at the Companies Listed Above
